Rapid, point-of-care antigen and molecular-based tests for diagnosis of SARS-CoV-2 infection

Jacqueline Dinnes, Jonathan J Deeks, Ada Adriano, Sarah Berhane, Clare Davenport, Sabine Dittrich, Devy Emperador, Yemisi Takwoingi, Jane Cunningham, Sophie Beese, Janine Dretzke, Lavinia Ferrante di Ruffano, Isobel M Harris, Malcolm J Price, Sian Taylor-Phillips, Lotty Hooft, Mariska Mg Leeflang, René Spijker, Ann Van den Bruel, Cochrane COVID-19 Diagnostic Test Accuracy Group, Jacqueline Dinnes, Jonathan J Deeks, Ada Adriano, Sarah Berhane, Clare Davenport, Sabine Dittrich, Devy Emperador, Yemisi Takwoingi, Jane Cunningham, Sophie Beese, Janine Dretzke, Lavinia Ferrante di Ruffano, Isobel M Harris, Malcolm J Price, Sian Taylor-Phillips, Lotty Hooft, Mariska Mg Leeflang, René Spijker, Ann Van den Bruel, Cochrane COVID-19 Diagnostic Test Accuracy Group

Abstract

Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the resulting COVID-19 pandemic present important diagnostic challenges. Several diagnostic strategies are available to identify or rule out current infection, identify people in need of care escalation, or to test for past infection and immune response. Point-of-care antigen and molecular tests to detect current SARS-CoV-2 infection have the potential to allow earlier detection and isolation of confirmed cases compared to laboratory-based diagnostic methods, with the aim of reducing household and community transmission.

Objectives: To assess the diagnostic accuracy of point-of-care antigen and molecular-based tests to determine if a person presenting in the community or in primary or secondary care has current SARS-CoV-2 infection.

Search methods: On 25 May 2020 we undertook electronic searches in the Cochrane COVID-19 Study Register and the COVID-19 Living Evidence Database from the University of Bern, which is updated daily with published articles from PubMed and Embase and with preprints from medRxiv and bioRxiv. In addition, we checked repositories of COVID-19 publications. We did not apply any language restrictions.

Selection criteria: We included studies of people with suspected current SARS-CoV-2 infection, known to have, or not to have SARS-CoV-2 infection, or where tests were used to screen for infection. We included test accuracy studies of any design that evaluated antigen or molecular tests suitable for a point-of-care setting (minimal equipment, sample preparation, and biosafety requirements, with results available within two hours of sample collection). We included all reference standards to define the presence or absence of SARS-CoV-2 (including reverse transcription polymerase chain reaction (RT-PCR) tests and established clinical diagnostic criteria).

Data collection and analysis: Two review authors independently screened studies and resolved any disagreements by discussion with a third review author. One review author independently extracted study characteristics, which were checked by a second review author. Two review authors independently extracted 2x2 contingency table data and assessed risk of bias and applicability of the studies using the QUADAS-2 tool. We present sensitivity and specificity, with 95% confidence intervals (CIs), for each test using paired forest plots. We pooled data using the bivariate hierarchical model separately for antigen and molecular-based tests, with simplifications when few studies were available. We tabulated available data by test manufacturer.

Main results: We included 22 publications reporting on a total of 18 study cohorts with 3198 unique samples, of which 1775 had confirmed SARS-CoV-2 infection. Ten studies took place in North America, two in South America, four in Europe, one in China and one was conducted internationally. We identified data for eight commercial tests (four antigen and four molecular) and one in-house antigen test. Five of the studies included were only available as preprints. We did not find any studies at low risk of bias for all quality domains and had concerns about applicability of results across all studies. We judged patient selection to be at high risk of bias in 50% of the studies because of deliberate over-sampling of samples with confirmed COVID-19 infection and unclear in seven out of 18 studies because of poor reporting. Sixteen (89%) studies used only a single, negative RT-PCR to confirm the absence of COVID-19 infection, risking missing infection. There was a lack of information on blinding of index test (n = 11), and around participant exclusions from analyses (n = 10). We did not observe differences in methodological quality between antigen and molecular test evaluations. Antigen tests Sensitivity varied considerably across studies (from 0% to 94%): the average sensitivity was 56.2% (95% CI 29.5 to 79.8%) and average specificity was 99.5% (95% CI 98.1% to 99.9%; based on 8 evaluations in 5 studies on 943 samples). Data for individual antigen tests were limited with no more than two studies for any test. Rapid molecular assays Sensitivity showed less variation compared to antigen tests (from 68% to 100%), average sensitivity was 95.2% (95% CI 86.7% to 98.3%) and specificity 98.9% (95% CI 97.3% to 99.5%) based on 13 evaluations in 11 studies of on 2255 samples. Predicted values based on a hypothetical cohort of 1000 people with suspected COVID-19 infection (with a prevalence of 10%) result in 105 positive test results including 10 false positives (positive predictive value 90%), and 895 negative results including 5 false negatives (negative predictive value 99%). Individual tests We calculated pooled results of individual tests for ID NOW (Abbott Laboratories) (5 evaluations) and Xpert Xpress (Cepheid Inc) (6 evaluations). Summary sensitivity for the Xpert Xpress assay (99.4%, 95% CI 98.0% to 99.8%) was 22.6 (95% CI 18.8 to 26.3) percentage points higher than that of ID NOW (76.8%, (95% CI 72.9% to 80.3%), whilst the specificity of Xpert Xpress (96.8%, 95% CI 90.6% to 99.0%) was marginally lower than ID NOW (99.6%, 95% CI 98.4% to 99.9%; a difference of -2.8% (95% CI -6.4 to 0.8)) AUTHORS' CONCLUSIONS: This review identifies early-stage evaluations of point-of-care tests for detecting SARS-CoV-2 infection, largely based on remnant laboratory samples. The findings currently have limited applicability, as we are uncertain whether tests will perform in the same way in clinical practice, and according to symptoms of COVID-19, duration of symptoms, or in asymptomatic people. Rapid tests have the potential to be used to inform triage of RT-PCR use, allowing earlier detection of those testing positive, but the evidence currently is not strong enough to determine how useful they are in clinical practice. Prospective and comparative evaluations of rapid tests for COVID-19 infection in clinically relevant settings are urgently needed. Studies should recruit consecutive series of eligible participants, including both those presenting for testing due to symptoms and asymptomatic people who may have come into contact with confirmed cases. Studies should clearly describe symptomatic status and document time from symptom onset or time since exposure. Point-of-care tests must be conducted on samples according to manufacturer instructions for use and be conducted at the point of care. Any future research study report should conform to the Standards for Reporting of Diagnostic Accuracy (STARD) guideline.

Conflict of interest statement

Jonathan J Deeks: none known

Jacqueline Dinnes: none known

Yemisi Takwoingi: none known

Clare Davenport: none known

Mariska MG Leeflang: none known

René Spijker: the Dutch Cochrane Centre (DCC) has received grants for performing commissioned systematic reviews. In no situation, the commissioner had any influence on the results of the work.

Lotty Hooft: none known

Ann Van den Bruel: none known

Devy Emperador: is employed by FIND with funding from DFID and KFW. FIND is a global non‐for profit product development partnership and WHO Diagnostic Collaboration Centre. It is FIND’s role to accelerate access to high quality diagnostic tools for low resource settings and this is achieved by supporting both R&D and access activities for a wide range of diseases, including COVID‐19. .FIND has several clinical research projects to evaluate multiple new diagnostic tests against published Target Product Profiles that have been defined through consensus processes. These studies are for diagnostic products developed by private sector companies who provide access to know‐how, equipment/reagents, and contribute through unrestricted donations as per FIND policy and external SAC review.

Sabine Dittrich: is employed by FIND with funding from DFID and Australian Aid. FIND is a global non‐for profit product development partnership and WHO Diagnostic Collaboration Centre. It is FIND’s role to accelerate access to high quality diagnostic tools for low resource settings and this is achieved by supporting both R&D and access activities for a wide range of diseases, including COVID‐19. .FIND has several clinical research projects to evaluate multiple new diagnostic tests against published Target Product Profiles that have been defined through consensus processes. These studies are for diagnostic products developed by private sector companies who provide access to know‐how, equipment/reagents, and contribute through unrestricted donations as per FIND policy and external SAC review.

Ada Adriano: none known

Sophie Beese: none known

Janine Dretzke: none known

Lavinia Ferrante di Ruffano: none known

Isobel Harris: none known

Malcolm Price: none known

Sian Taylor‐Phillips: none known

Sarah Berhane: is funded by NIHR Birmingham Biomedical Research Centre.

Jane Cunningham: none known

Copyright © 2020 The Authors. Cochrane Database of Systematic Reviews published by John Wiley & Sons, Ltd. on behalf of The Cochrane Collaboration.

Figures

1
1
Study flow diagram
2
2
Risk of bias and applicability concerns graph: review authors' judgements about each domain presented as percentages across included studies. Numbers in the bars indicate the number of studies
3
3
Forest plot of studies evaluating antigen tests. Studies grouped by test
(FIA: fluorescence immunoassays; CGIA: colloidal gold‐based immunoassays; NP: nasopharyngeal; OP: oropharyngeal)
4
4
Forest plot of studies evaluating rapid molecular tests. Studies grouped by test and sample type
(NP: nasopharyngeal; OP: oropharyngeal; RUO: research use only)
5
5
Forest plot of studies evaluating antigen tests according to viral load: high (≤ 25 Ct) versus low viral load (≤ 30 Ct in Diao 2020). Studies grouped by test
6
6
Forest plot of studies evaluating rapid molecular tests according to viral load: high (≤ 30 Ct) versus low viral load. Studies grouped by test
7
7
Forest plot of studies of molecular tests before and after discrepant analysis. Studies grouped by test
(DRW: Diagnostics for the Real World; RUO: research use only)
8
8
Risk of bias and applicability concerns summary: review authors' judgements about each domain for each included study
1. Test
1. Test
Antigen tests ‐ All
2. Test
2. Test
Antigen tests ‐ high viral load
3. Test
3. Test
Antigen tests ‐ low viral load
4. Test
4. Test
Molecular tests ‐ all
5. Test
5. Test
Molecular tests ‐ all (before discrepant analysis)
6. Test
6. Test
Molecular tests ‐ all (after discrepant analysis)
7. Test
7. Test
Molecular tests ‐ high viral load
8. Test
8. Test
Molecular tests ‐ low viral load

References

References to studies included in this review Assennato 2020 {published data only}

    1. Assennato SM, Ritchie AV, Nadala C, Goel N, Zhang H, Datir R, et al. Performance evaluation of the point-of-care SAMBA II SARS-CoV-2 test for detection of SARS-CoV-2. medRxiv [Preprint] 24 May 2020. [DOI: 10.1101/2020.05.24.20100990]
Broder 2020 {published data only}
    1. Broder K, Babiker A, Myers C, White T, Jones H, Cardella J, et al. Test agreement between Roche cobas 6800 and Cepheid GeneXpert Xpress SARS-CoV-2 assays at high cycle threshold ranges. Journal of Clinical Microbiology 2020;58:e01187-20. [DOI: 10.1128/JCM.01187-20]
    1. Broder KJ, Babiker A, Myers C, White T, Jones H, Cardella J, et al. Test agreement between Roche cobas 6800 and Cepheid GeneXpert Xpress SARS-CoV-2 assays at high cycle threshold ranges. bioRxiv [Preprint] 5 May 2020:1-13. [DOI: 10.1101/2020.05.05.078501]
Diao 2020 {published data only}
    1. Diao B, Wen K, Chen J, Liu Y, Yuan Z, Han C, et al. Diagnosis of acute respiratory syndrome coronavirus 2 infection by detection of nucleocapsid protein. medRxiv [Preprint] 10 March 2020:1-13. [DOI: 10.1101/2020.03.07.20032524]
Harrington 2020 {published data only}
    1. Harrington A, Cox B, Snowdon J, Bakst J, Ley E, Grajales P, et al. Comparison of Abbott ID NOW and Abbott m2000 methods for the detection of SARS-CoV-2 from nasopharyngeal and nasal swabs from symptomatic patients. Journal of Clinical Microbiology 2020;58(8):e00798-20. [DOI: 10.1128/JCM.00798-20.]
Hogan 2020 {published data only}
    1. Hogan CA, Garamani N, Lee AS, Tung JK, Sahoo MK, Huang C, et al. Comparison of the Accula SARS-CoV-2 test with a laboratory-developed assay for detection of SARS-CoV-2 RNA in clinical nasopharyngeal specimens. bioRxiv [Preprint] 2020. [DOI: 10.1101/2020.05.12.092379v1]
Lambert‐Niclot 2020 {published data only}
    1. Lambert-Niclot S, Cuffel A, Le Pape S, Vauloup-Fellous C, Morand-Joubert L, Roque-Afonso AM, et al. Evaluation of a rapid diagnostic assay for detection of SARS CoV-2 antigen in nasopharyngeal swab. Journal of Clinical Microbiology 2020;58(8):e00977-20. [DOI: 10.1128/JCM.00977-20]
Lieberman 2020 {published data only}
    1. Lieberman JA, Pepper G, Naccache SN, Huang ML, Jerome KR, Greninger AL. Comparison of commercially available and laboratory developed assays for in vitro detection of SARS-CoV-2 in clinical laboratories. Journal of Clinical Microbiology 2020;58(8):e00821-20. [DOI: 10.1128/JCM.00821-20]
Loeffelholz 2020 {published data only}
    1. Loeffelholz MJ, Alland D, Butler-Wu SM, Pandey U, Perno CF, Nava A, et al. Multicenter evaluation of the Cepheid Xpert Xpress SARS-CoV-2 test. Journal of Clinical Microbiology 2020;58(8):e00926-20. [DOI: 10.1128/JCM.00926-20]
Mertens 2020 {published data only}
    1. Mertens P, De Vos N, Martiny D, Jassoy C, Mirazimi A, Cuypers L, et al. Development and potential usefulness of the COVID-19 Ag Respi-Strip diagnostic assay in a pandemic context. medRxiv [Preprint] 24 April 2020:1-29. [DOI: 10.1101/2020.04.24.20077776]
Mitchell 2020 {published data only}
    1. Mitchell SL, George KS. Evaluation of the COVID19 ID NOW EUA assay. Journal of Clinical Virology 2020;128:104429. [DOI: 10.1016/j.jcv.2020.104429]
Moore 2020 {published data only}
    1. Moore NM, Li H, Schejbal D, Lindsley J, Hayden M. Comparison of two commercial molecular tests and a laboratory-developed modification of the CDC 2019-nCOV RT-PCR assay for the qualitative detection of SARS-CoV-2 from upper respiratory tract specimens. medRxiv [Preprint] 2020:1-22. [DOI: 10.1101/2020.05.02.20088740]
Moran 2020 {published data only}
    1. Moran A, Beavis KG, Matushek SM, Ciaglia C, Francois N, Tesic V, et al. The detection of SARS-CoV-2 using the Cepheid Xpert Xpress SARS-CoV-2 and Roche cobas SARS-CoV-2 assays. Journal of Clinical Microbiology 2020;58(8):e00772-20. [DOI: 10.1128/JCM.00772-20]
Porte 2020 {published data only}
    1. Porte L, Legarraga P, Vollrath V, Aguilera X, Munita JM, Araos R, et al. Evaluation of novel antigen-based rapid detection test for the diagnosis of SARS-CoV-2 in respiratory samples. 14 April 2020:1-23.
Rhoads 2020 {published data only}
    1. Rhoads DD, Cherian SS, Roman K, Stempak LM, Schmotzer CL, Sadri N. Comparison of Abbott ID NOW, Diasorin Simplexa, and CDC FDA EUA methods for the detection of SARS-CoV-2 from nasopharyngeal and nasal swabs from individuals diagnosed with COVID-19. Journal of Clinical Microbiology 2020;58(8):e00760-20. [DOI: 10.1128/JCM.00760-20]
Smithgall 2020 [A] {published data only}
    1. Smithgall MC, Scherberkova I, Whittier S, Green D. Comparison of Cepheid Xpert Xpress and Abbott ID Now to Roche cobas for the rapid detection of SARS-CoV-2. bioRxiv [Preprint] 25 April 2020:1-16. [DOI: 10.1101/2020.04.22.055327]
    1. Smithgall MC, Scherberkova I, Whittier S, Green DA. Comparison of Cepheid Xpert Xpress and Abbott ID Now to Roche Cobas for the rapid detection of SARS-CoV-2. Journal of Clinical Virology 2020;128:104428. [DOI: 10.1016/j.jcv.2020.104428]
Smithgall 2020 [B] {published data only}
    1. Smithgall MC, Scherberkova I, Whittier S, Green DA. Comparison of Cepheid Xpert Xpress and Abbott ID Now to Roche Cobas for the rapid detection of SARS-CoV-2. Journal of Clinical Virology 2020;128:104428. [DOI: 10.1016/j.jcv.2020.104428]
Weitzel 2020 [A] {published data only}
    1. Weitzel T, Legarraga P, Iruretagoyena M, Pizarro G, Vollrath V, Araos R, et al. Head-to-head comparison of four antigen-based rapid detection tests for the diagnosis of SARS-CoV-2 in respiratory samples. bioRxiv [Preprint] 30 May 2020:1-21. [DOI: 10.1101/2020.05.27.119255]
Weitzel 2020 [B] {published data only}
    1. Weitzel T, Legarraga P, Iruretagoyena M, Pizarro G, Vollrath V, Araos R, et al. Head-to-head comparison of four antigen-based rapid detection tests for the diagnosis of SARS-CoV-2 in respiratory samples. bioRxiv [Preprint] 30 May 2020:1-21. [DOI: 10.1101/2020.05.27.119255]
Weitzel 2020 [C] {published data only}
    1. Weitzel T, Legarraga P, Iruretagoyena M, Pizarro G, Vollrath V, Araos R, et al. Head-to-head comparison of four antigen-based rapid detection tests for the diagnosis of SARS-CoV-2 in respiratory samples. bioRxiv [Preprint] 30 May 2020:1-21. [DOI: 10.1101/2020.05.27.119255]
Weitzel 2020 [D] {published data only}
    1. Weitzel T, Legarraga P, Iruretagoyena M, Pizarro G, Vollrath V, Araos R, et al. Head-to-head comparison of four antigen-based rapid detection tests for the diagnosis of SARS-CoV-2 in respiratory samples. bioRxiv [Preprint] 30 May 2020:1-21. [DOI: 10.1101/2020.05.27.119255]
Wolters 2020 {published data only}
    1. Wolters F, Van de Bovenkamp J, Van den Bosch B, Van den Brink S, Broeders M, Chung NH, et al. Multi-center evaluation of Cepheid Xpert(R) Xpress SARS-CoV-2 point-of-care test during the SARS-CoV-2 pandemic. Journal of Clinical Virology 2020;128:104426. [DOI: 10.1016/j.jcv.2020.104426]
Zhen 2020 [A] {published data only}
    1. Zhen W, Smith E, Manji R, Schron D, Berry GJ. Clinical evaluation of three sample-to-answer platforms for the detection of SARS-CoV-2. Journal of Clinical Microbiology 2020;58(8):e00783-20. [DOI: 10.1128/JCM.00783-20]
Zhen 2020 [B] {published data only}
    1. Zhen W, Smith E, Manji R, Schron D, Berry GJ. Clinical evaluation of three sample-to-answer platforms for the detection of SARS-CoV-2. Journal of Clinical Microbiology 2020;58(8):e00783-20. [DOI: 10.1128/JCM.00783-20]
References to studies excluded from this review Ai 2020 {published data only}
    1. Ai JW, Zhang HC, Xu T, Wu J, Zhu M, Yu YQ, et al. Optimizing diagnostic strategy for novel coronavirus pneumonia, a multi-center study in Eastern China. medRxiv [Preprint] 17 February 2020:1-18. [DOI: 10.1101/2020.02.13.20022673]
Anahtar 2020 {published data only}
    1. Anahtar MN, McGrath GE, Rabe BA, Tanner NA, White BA, Lennerz JK, et al. Clinical assessment and validation of a rapid and sensitive SARS-CoV-2 test using reverse-transcription loop-mediated isothermal amplification. medRxiv [Preprint] 18 May 2020:1-22. [DOI: 10.1101/2020.05.12.20095638]
Arumugam 2020 {published data only}
    1. Arumugam A, Faron ML, Yu P, Markham C, Wong S. A rapid COVID-19 RT-PCR detection assay for low resource settings. bioRxiv [Preprint] 30 April 2020:1-13. [DOI: 10.1101/2020.04.29.069591]
Baek 2020 {published data only}
    1. Baek YH, Um J, Antigua KJ, Park JH, Kim Y, Oh S, et al. Development of a reverse transcription-loop-mediated isothermal amplification as a rapid early-detection method for novel SARS-CoV-2. Emerging Microbes & Infections 2020;9(1):998-1007.
Barra 2020 {published data only}
    1. Barra GB, Ticiane Henriques SR, Goes MP, Henriques JR, Nery LF. Analytical sensibility and specificity of two RT-qPCR protocols for SARS-CoV-2 detection performed in an automated workflow. medRxiv [Preprint] 10 March 2020:1-5. [DOI: 10.1101/2020.03.07.20032326]
Basu 2020 {published data only}
    1. Basu A, Zinger T, Inglima K, Woo KM, Atie O, Yurasits L, et al. Performance of Abbott ID NOW COVID-19 rapid nucleic acid amplification test in nasopharyngeal swabs transported in viral media and dry nasal swabs, in a New York City academic institution. Journal of Clinical Microbiology 2020;58(8):e01136-20. [DOI: 10.1128/JCM.01136-20]
Behrmann 2020 {published data only}
    1. Behrmann O, Bachmann I, Spiegel M, Schramm M, El Wahed AA, Dobler G, et al. Rapid detection of SARS-CoV-2 by low volume real-time single tube reverse transcription recombinase polymerase amplification using an exo probe with an internally linked quencher (exo-IQ). Clinical Chemistry 8 May 2020 [Epub ahead of print]:hvaa116. [DOI: 10.1093/clinchem/hvaa116]
Bordi 2020 {published data only}
    1. Bordi L, Piralla A, Lalle E, Giardina F, Colavita F, Tallarita M, et al. Rapid and sensitive detection of SARS-CoV-2 RNA using the Simplexa COVID-19 direct assay. Journal of Clinical Virology 2020;128:104416.
Broughton 2020 {published data only}
    1. Broughton JP, Deng X, Yu G, Fasching CL, Singh J, Streithorst J, et al. Rapid detection of 2019 novel coronavirus SARS-CoV-2 using a CRISPR-based DETECTR lateral flow assay. medRxiv [Preprint] 27 March 2020:1-28. [DOI: 10.1101/2020.03.06.20032334]
Callahan 2020 {published data only}
    1. Callahan CJ, Lee R, Zulauf K, Tamburello L, Smith KP, Previtera J, et al. Open development and clinical validation of multiple 3D-printed sample-collection swabs: rapid resolution of a critical COVID-19 testing bottleneck. medRxiv [Preprint] 7 May 2020:1-16. [EMBASE: 10.1101/2020.04.14.20065094]
    1. Callahan CJ, Lee R, Zulauf KE, Tamburello L, Smith KP, Previtera J, et al. Open development and clinical validation of multiple 3D-printed nasopharyngeal collection swabs: rapid resolution of a critical COVID-19 testing bottleneck. Journal of Clinical Microbiology 2020;58(8):e00876-20. [DOI: 10.1128/JCM.00876-20]
Chandler‐Brown 2020 {published data only}
    1. Chandler-Brown D, Bueno AM, Atay O, Tsao DS. A highly scalable and rapidly deployable RNA extraction-free COVID-19 assay by quantitative Sanger sequencing. medRxiv [Preprint] 10 April 2020:1-15. [DOI: 10.1101/2020.04.07.029199]
Colson 2020 {published data only}
    1. Colson P, Lagier JC, Baudoin JP, Bou Khalil J, La Scola B, Raoult D. Ultrarapid diagnosis, microscope imaging, genome sequencing, and culture isolation of SARS-CoV-2. European Journal of Clinical Microbiology & Infectious Diseases 2020;39(8):1601-3.
Comar 2020 {published data only}
    1. Comar M, Brumat M, Concas MP, Argentini G, Bianco A, Bicego L, et al. COVID-19 experience: first Italian survey on healthcare staff members from a Mother-Child Research hospital using combined molecular and rapid immunoassays test. medRxiv [Preprint] 22 April 2020:1-12. [DOI: 10.1101/2020.04.19.20071563]
Crone 2020 {published data only}
    1. Crone MA, Priestman M, Ciechonska M, Jensen K, Sharp DJ, Randell P, et al. A new role for Biofoundries in rapid prototyping, development, and validation of automated clinical diagnostic tests for SARS-CoV-2. medRxiv [Preprint] 12 May 2020:1-31. [DOI: 10.1101/2020.05.02.20088344]
Curti 2020 {published data only}
    1. Curti L, Pereyra-Bonnet F, Gimenez CA. An ultrasensitive, rapid, and portable coronavirus SARS-CoV-2 sequence detection method based on CRISPR-Cas12. bioRxiv [Preprint] 2 March 2020:1-10. [DOI: 10.1101/2020.02.29.971127]
Ding 2020 {published data only}
    1. Ding X, Yin K, Li Z, Liu C. All-in-One Dual CRISPR-Cas12a (AIOD-CRISPR) assay: a case for rapid, ultrasensitive and visual detection of novel coronavirus SARS-CoV-2 and HIV virus. bioRxiv [Preprint] 21 March 2020:1-19. [DOI: 10.1101/2020.03.19.998724]
Dohla 2020 {published data only}
    1. Dohla M, Boesecke C, Schulte B, Diegmann C, Sib E, Richter E, et al. Rapid point-of-care testing for SARS-CoV-2 in a community screening setting shows low sensitivity. Public Health 2020;182:170-2.
Farfan 2020 {published data only}
    1. Farfan MJ, Torres JP, Oryan M, Olivares M, Gallardo P, Salas C. Optimizing RT-PCR detection of SARS-CoV-2 for developing countries using pool testing. medRxiv [Preprint] 17 April 2020:1-10. [DOI: 10.1101/2020.04.15.20067199]
Francis 2020 {published data only}
    1. Francis R, Le Bideau M, Jardot P, Grimaldier C, Raoult D, Khalil JY, et al. High speed large scale automated isolation of SARS-CoV-2 from clinical samples using miniaturized co-culture coupled with high content screening. bioRxiv [Preprint] 19 May 2020:1-23. [DOI: 10.1101/2020.05.14.097295]
Freire‐Paspuel 2020 {published data only}
    1. Freire-Paspuel B, Vega-Marino P, Velez A, Cruz M, Bereguiain MA. High sensitivity CDC EUA SARS-CoV-2 kit-based End Point-PCR assay. medRxiv [Preprint] 18 May 2020:1-7. [DOI: 10.1101/2020.05.11.20098590]
Ganguli 2020 {published data only}
    1. Ganguli A, Mostafa A, Berger J, Aydin M, Sun F, Valera E, et al. Rapid isothermal amplification and portable detection system for SARS-CoV-2. bioRxiv [Preprint] 21 May 2020:1-31. [DOI: 10.1101/2020.05.21.108381]
Giamarellos‐Bourboulis 2020 {published data only}
    1. Giamarellos-Bourboulis EJ, Netea MG, Rovina N, Akinosoglou K, Antoniadou A, Antonakos N, et al. Complex immune dysregulation in COVID-19 patients with severe respiratory failure. Cell Host & Microbe 2020;27(6):992-1000 e3.
Gonzalez‐Gonzalez 2020 {published data only}
    1. Gonzalez-Gonzalez E, Lara-Mayorga IM, Rodriguez-Sanchez IP, Yee-de Leon F, Garcia-Rubio A, Garciamendez-Mijares CE, et al. Scaling diagnostics in times of COVID-19: rapid prototyping of 3D-printed water circulators for Loop-mediated Isothermal Amplification (LAMP) and detection of SARS-CoV-2 virus. medRxiv [Preprint] 19 June 2020:1-39. [DOI: 10.1101/2020.04.09.20058651]
Grant 2020 {published data only}
    1. Grant PR, Turner MA, Shin GY, Nastouli E, Levett LJ. Extraction-free COVID-19 (SARS-CoV-2) diagnosis by RT-PCR to increase capacity for national testing programmes during a pandemic. bioRxiv [Preprint] 9 April 2020:1-6.
Hass 2020 {published data only}
    1. Hass KN, Bao M, He Q, Park M, Qin P, Du K. Integrated Micropillar Polydimethylsiloxane Accurate CRISPR Detection (IMPACT) system for rapid viral DNA sensing. bioRxiv [Preprint] 20 March 2020:1-10. [DOI: 10.1101/2020.03.17.994137]
Hogan 2020a {published data only}
    1. Hogan CA, Sahoo MK, Huang C, Garamani N, Stevens B, Zehnder J, et al. Comparison of the Panther Fusion and a laboratory-developed test targeting the envelope gene for detection of SARS-CoV-2. Journal of Clinical Virology 2020;127:104383.
Hu 2020 {published data only}
    1. Hu X, Deng Q, Li J, Chen J, Wang Z, Zhang X, et al. Development and clinical application of a rapid and sensitive loop-mediated isothermal amplification test for SARS-CoV-2 infection. medRxiv [Preprint] 29 May 2020:1-28. [DOI: 10.1101/2020.05.20.20108530]
Huang 2020 {published data only}
    1. Huang WE, Lim B, Hsu CC, Xiong D, Wu W, Yu Y, et al. RT-LAMP for rapid diagnosis of coronavirus SARS-CoV-2. Microbial Biotechnology 2020;13(4):950-61.
Jiang 2020 {published data only}
    1. Jiang M, Pan W, Arastehfar A, Fang W, ling L, Fang H, et al. Development and validation of a rapid single-step reverse transcriptase loop-mediated isothermal amplification (RT-LAMP) system potentially to be used for reliable and high-throughput screening of COVID-19. medRxiv [Preprint] 27 March 2020:1-12. [DOI: 10.1101/2020.03.15.20036376]
Joung 2020 {published data only}
    1. Joung J, Ladha A, Saito M, Segel M, Bruneau R, Huang MW, et al. Point-of-care testing for COVID-19 using SHERLOCK diagnostics. medRxiv [Preprint] 8 May 2020:1-21. [DOI: 10.1101/2020.05.04.20091231]
Kalikiri 2020 {published data only}
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Kim 2019 {published data only}
    1. Kim JH, Kang M, Park E, Chung DR, Kim J, Hwang ES. A simple and multiplex Loop-Mediated isothermal Amplification (LAMP) assay for rapid detection of SARS-CoV. Biochip Journal 2019;13(4):341-51.
Konrad 2020 {published data only}
    1. Konrad R, Eberle U, Dangel A, Treis B, Berger A, Bengs K, et al. Rapid establishment of laboratory diagnostics for the novel coronavirus SARS-CoV-2 in Bavaria, Germany, February 2020. Euro Surveillance 2020;25(9):2000173.
Kurstjens 2020 {published data only}
    1. Kurstjens S, Van der Horst A, Herpers R, Geerits MW, Kluiters-de Hingh YC, Göttgens E-L, et al. Rapid identification of SARS-CoV-2-infected patients at the emergency department using routine testing. bioRxiv [Preprint] 4 April 2020:1-21. [DOI: 10.1101/2020.04.20.20067512]
Lalli 2020 {published data only}
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Lamb 2020 {published data only}
    1. Lamb LE, Bartolone SN, Ward E, Chancellor MB. Rapid detection of novel coronavirus (COVID-19) by reverse transcription-loop-mediated isothermal amplification. medRxiv [Preprint] 24 February 2020:1-17. [DOI: 10.1101/2020.02.19.20025155]
Lee 2020 {published data only}
    1. Lee JY, Best N, McAuley J, Porter JL, Seemann T, Schultz MB, et al. Validation of a single-step, single-tube reverse transcription-loop-mediated isothermal amplification assay for rapid detection of SARS-CoV-2 RNA. bioRxiv [Preprint] 30 April 2020:1-32. [DOI: 10.1101/2020.04.28.067363]
Lin 2020 {published data only}
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Lowe 2020 {published data only}
    1. Lowe CF, Matic N, Ritchie G, Lawson T, Stefanovic A, Champagne S, et al. Detection of low levels of SARS-CoV-2 RNA from nasopharyngeal swabs using three commercial molecular assays. Journal of Clinical Virology 2020;128:104387.
Lu 2020 {published data only}
    1. Lu R, Wu X, Wan Z, Li Y, Zuo L, Qin J, et al. Development of a novel reverse transcription loop-mediated isothermal amplification method for rapid detection of SARS-CoV-2. Virologica Sinica 2020;35(3):344-7.
Lu 2020a {published data only}
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Mahari 2020 {published data only}
    1. Mahari S, Roberts A, Shahdeo D, Gandhi S. eCovSens-Ultrasensitive novel in-house built printed circuit board based electrochemical device for rapid detection of nCOVID-19 antigen, a spike protein domain 1 of SARS-CoV-2. bioRxiv [Preprint] 11 May 2020:1-20. [DOI: 10.1101/2020.04.24.059204]
Marzinotto 2020 {published data only}
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McRae 2020 {published data only}
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Mei 2020 {published data only}
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    1. Osterdahl MF, Lee KA, Ni LM, Wilson S, Douthwaite S, Horsfall R, et al. Detecting SARS-CoV-2 at point of care: preliminary data comparing Loop-mediated Isothermal Amplification (LAMP) to PCR. medRxiv [Preprint] 4 April 2020:1-9. [DOI: 10.1101/2020.04.01.20047357]
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Seo 2020 {published data only}
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    1. St Hilaire BG, Durand NC, Mitra N, Pulido SG, Mahajan R Blackburn A, et al. A rapid, low cost, and highly sensitive SARS-CoV-2 diagnostic based on whole genome sequencing. bioRxiv [Preprint] 11 May 2020:1-29. [DOI: 10.1101/2020.04.25.061499]
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Zeng 2020 {published data only}
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Zhang 2020 {published data only}
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Zhao 2020 {published data only}
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